Cough Relief

Set ID
12a14331-58e5-42dd-81c6-c53f62804d7b
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:42:13

Key Label Information

Active Ingredients And Purpose

Active Ingredient (in each tablet)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Uses

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• a cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use

Directions And Dosage

Directions

do not take more than 8 softgels in any 24-hour period this adult product is not intended for use in children under 12 years of age adults & children 12 years & over take 2 softgels every 6 to 8 hours, as needed children under 12 years of age do not use

Other Label Information

Other information

• store at 20–25°C (68–77°F) • avoid excessive heat above 40°C (104°F) • protect from light

Inactive ingredients

FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone,sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-888-333-9792

Display Panel

PACKAGE NOT CHILD-RESISTANT CABINET Cough Relief Active ingredient: DEXTROMETHORPHAN HBr 15 MG Cough Suppressant Relieves Cough up to 8 Hours Non-Drowsy Non-Narcotic CABINET: The Sustainable Healthcare Co.™

Products

NDC Codes

Ingredients

NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONEFZ989GH94EIACT
SORBITOL SOLUTION8KW3E207O2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

Complete SPL Sections

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 15 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

WARNINGS SECTION

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• a cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than 8 softgels in any 24-hour period this adult product is not intended for use in children under 12 years of age adults & children 12 years & over take 2 softgels every 6 to 8 hours, as needed children under 12 years of age do not use

Other information

STORAGE AND HANDLING SECTION

• store at 20–25°C (68–77°F) • avoid excessive heat above 40°C (104°F) • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone,sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Cabinet Health P.B.C.

Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE NOT CHILD-RESISTANT CABINET Cough Relief Active ingredient: DEXTROMETHORPHAN HBr 15 MG Cough Suppressant Relieves Cough up to 8 Hours Non-Drowsy Non-Narcotic CABINET: The Sustainable Healthcare Co.™

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc2903a730-bbbf-a22b-e063-6294a90a54b8.xml2024-12-13
otc0bdf7c4c-ecad-a69e-e063-6394a90a1139.xml2023-12-07
otcef1a81f7-6aca-9c32-e053-2a95a90aee66.xml2022-12-06
otcCough Relief PDP.jpg2021-11-18
otcd1007656-c970-4823-e053-2995a90a7d5e.xml2021-11-18